NCT01266759已完成不适用
Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart.
研究概览
简要总结
To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control cycles)and desire contraception
排除标准
- •Menorrhagia of endocrine or systemic origin
- •other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.
研究组 & 干预措施
NuvaRing
Experimental
For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.
干预措施: NuvaRing (Drug)
Norethisterone Acetate
Active Comparator
Norethisterone Acetate tablets at a dose of 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment
干预措施: Norethisterone Acetate tablets - 5mg (Drug)
结局指标
主要结局
Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart.
次要结局
- Haemoglobin and serum ferritin at the end of study (cycle 3)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
COMPARISON OF VAGINAL CONTRACEPTIVE RING (NUVARING) AND ORAL CONTRACEPTIVE PILL (MALA N) FOR THE TREATMENT OF LOWER ABDOMINAL PAIN PERSISTING FOR SIX OR MORE MONTHS.CTRI/2013/05/003706GTB HOSPITA66
终止
不适用
NuvaRing vs. Oral Contraceptive Pills (OCP) for In-Vitro Fertilization (IVF) Pre-treatmentIn-vitro FertilizationInfertilityNCT01298128University of Toronto70
已完成
2 期
Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ARTHIV-1 InfectionNCT01903031Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections84
已完成
4 期
Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local ImmunityBacterial VaginosisNCT02432404University of Washington81
尚未招募
不适用
Trial on use of different route of contraceptive hormones (vaginal contraceptive Ring versus Combined Contraceptive pills) in management of heavy menstrual bleeding: A Randomized StudyCTRI/2017/07/009048Department of Obst Gynae Armed Forces Medical CollegeAFMC Pune Maharashtra India